Quality Risk Management Software System — Qualio
RISK MANAGEMENT
Identify and mitigate risks before they become findings
Proactive risk identification, mitigation, and resolution in a dedicated risk platform. Connected to your design controls and quality events.
Risk management software solutions to give your business confidence
Challenge
Risks lurk in every nook and cranny of your business. Pinpointing and tackling every single one is extremely difficult.
And when you do get a risk management system in place, it doesn't always integrate with your product design and development processes - leaving crucial risks undetected and unresolved as you get to market.
Solution
Qualio's risk software embeds risk management into the heart of your product design and development activities.
Total visibility, bespoke action workflows and automated document stack creation removes the effort and headache of risk management and lets you bring a safe, compliant product to your patients and customers.
Detect vulnerabilities across your entire organization
- Build a single source of truth for risk identification, monitoring and remediation
- Save time and money by identifying risks early in product development
- Connect your quality and product teams in a single risk assessment software environment that keeps risk-based thinking front and center
Unlock deep risk visibility with an acceptability matrix
- Define your risk criteria then apply them across a connected risk management software platform
- Link risks to your product development design control and documentation processes to squash risks for a right-first-time approach
- Seamlessly access risk analysis and traceability matrices with one click
Embed ISO 14971 and FMEA
- Use our ISO 14971 software to embed lasting compliance into your medical device design controls
- Show complete FMEA-based risk control to your auditors
- Export risk records and link risks to CAPA plans and Qualio documents
Quality risk management system resources
ISO 13485 risk management plan template
Build a structured medical device risk management plan with our pre-built template.
Mastering risks and opportunities webinar
Build a holistic risk management system that squashes risk and harnesses opportunity.
See other features that make Qualio the #1 top-rated compliance and risk management software
Document management
Make paper, filing cabinets, folders and spreadsheets a thing of the past.
Design control management
Supercharge your product development from a single source of truth.
Training management
Build a competent, confident, compliant, continuously improving workforce.
Change control management
Manage change activity easily and effectively with complete traceability.
Audit management
Make compliance and audit readiness the natural core of your business DNA.
CAPA & NCR management
Build automated response workflows for any quality event.
Supplier management
Control and categorize suppliers and third parties with complete visibility.
Compliance management
Get audit-ready in weeks, stay audit-ready forever.
Trusted by 500+ life sciences companies
Hear from our customers
“We’re building a quality product. So we bought a tool that gives us a quality culture. Instead of pushing quality to one department, Qualio breaks down that barrier.”
Daniel A.
Chief Technology Officer, InVivo Bionics
"When you're using paper, you're not moving forward. You can't. Now we're so streamlined, we're finally making progress. We're talking about bringing a new product into design controls right now. I don't think that'd be possible if we didn't have Qualio."
Ami A.
Director of Ops & Quality Management, NeuFit
"I’ve never been more confident in my 27 years of being audited."
Lowell H.
Director of Quality Assurance, Restech
"Qualio is the best QMS cloud-based system I have ever seen."
Paul H.
Senior VP of Ops, Tech & Quality, Advantice Health
"You're going to be able to get this thing in-house, validated, implemented and live in a short amount of time with limited resources. That's unique in this industry."
Becki N.
Quality & Regulatory Lead, Synthego
"We were able to complete a demanding audit thanks to Qualio. The smart links made navigating between processes seamless and easy to understand."
Thais S.
Head of Quality & Regulatory Affairs, Cergenx
“Qualio has helped make my life as a quality manager very easy.”
Gene V.
Quality Manager, Cirris
Additional Testimonials
- "Qualio keeps us in a constant state of audit readiness." - Deb G. - Director of Quality, Dimension Therapeutics
- "I contacted Qualio in November. We went live mid-December. We had all users in by January. And we had our ISO 13485 certification in July. Without Qualio, we'd never have done that."
- Karen H.
- Head of Quality & GxP Compliance, 30 Technology
- "Qualio has been great to work with. We implemented an entire QMS with them! Intuitive functionality, friendly staff."
- Kim K.
- Executive VP of Operations, VirTrial